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Lucira Health introduced it had filed for Chapter 11 chapter final week simply because the diagnostics firm obtained Emergency Use Authorization from the FDA for an at-home mixture COVID-19 and flu check.
Within the firm’s bankruptcy filing, it lists about $146 million in belongings and liabilities of round $85 million. Lucira plans to make use of roughly $4.5 million money available to fund operations because it seeks to promote itself.
The corporate mentioned it noticed much less demand for its residence COVID-19 check in 2022, and the FDA’s regulatory course of for its mixture check took longer than anticipated.
“We remorse that we had no possibility however to file for Chapter 11 chapter and that this occurred days earlier than we obtained regulatory authorization,” Erik Engelson, president and CEO of Lucira Well being, mentioned in an announcement. “Sadly we have been unable to bridge what turned a protracted authorization cycle time inside our present capital construction and it remained unclear to us when the regulatory authorization would come via, regardless of working intently with FDA. The Lucira COVID-19 & Flu Residence Take a look at would have been particularly helpful throughout the current, extreme respiratory season, and we had produced stock for an anticipated autumn 2022 launch.”
The mix check marks the first authorization for an over-the-counter and at-home diagnostic that may detect and differentiate between the viruses that trigger flu and COVID-19. It makes use of a nasal swab to supply ends in about half-hour.
“At this time’s authorization of the primary OTC check that may detect Influenza A and B, together with SARS-CoV-2, is a serious milestone in bringing larger client entry to diagnostic assessments that may be carried out totally at residence,” Dr. Jeff Shuren, director of the FDA’s Heart for Gadgets and Radiological Well being, mentioned in an announcement. “The FDA strongly helps innovation in check improvement, and we’re wanting to proceed advancing larger entry to at-home infectious illness testing to greatest assist public well being wants. We stay dedicated to working with check builders to assist the shared objective of getting extra correct and dependable assessments to Individuals who want them.”
THE LARGER TREND
Based in 2013, Lucira obtained Emergency Use Authorization for its COVID-19 residence check in late 2020. In October, the corporate mentioned it would lay off 56 employees, or a few quarter of its workforce.
Many digital well being and well being tech corporations have struggled financially after increasing and elevating large amounts of cash in 2021. One other residence diagnostics firm, Cue Well being, just lately announced plans to cut 26% of its workforce.
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